The concept of using heat to treat degenerated disc tissue is conventionally known. For example, the orthopedic company ORATEC Interventions, Inc. has developed and marketed a device for thermal spine treatment based on Intra-Discal Electro-Thermal (IDET) technology. IDET technology involves a minimally invasive catheter using RF induction of a hot-wire tip for thermal conduction.
While relatively straightforward in design and use, the ORATEC device is very limited in thermal capabilities and ultimately in treatment efficacy. The region of disc tissue that is heated with this device is quite small with a sharp temperature fall-off from the surface of the catheter tip (therapeutic temperature elevation in the tissue is estimated to be only 1-3 mm from the catheter). As a result, the treatment itself is likely limited in effectiveness for any given patient, simply because the volume of tissue that is heated is not large enough to produce a significant therapeutic effect (i.e., shrinkage of collagen fibers, destruction of invading nerves, and/or reduction of pressure on the spinal nerves).
Furthermore, the design and treatment approach of the IDET catheter is significantly limiting in the general treatment population—it is estimated that more than 50% of the potential treatment population is not even a candidate for this device therapy. This is due to the use of a flexible “navigable catheter” which must be circumnavigated around the disc border between the annulus and the nucleus, positioning the treatment tip back at the posterior region of the degenerated disc. This positioning is possible with a healthy or slightly degenerated disc because the fibers of the annulus help “steer” the catheter around the disc tissue. However, with greater disc degeneration, this positioning is not possible because of the tissue degradation; there is no structure for the catheter to steer around, providing the danger of slippage and puncturing the opposite wall. As a result, the majority of patients, especially those with advanced degeneration or herniation, cannot be treated with this approach.